Byline: Erem Latif
Over the past 12 years, there has been a growing emphasis on exploring the social determinants of health. Our comprehension of how economic stability, community dynamics, access to resources, and the quality of education, among various other nuanced elements, significantly influence an individual's health, quality of life, and overall outcomes has substantially expanded. The U.S. Office of Disease Prevention and Health Promotion has even launched the Healthy People 2030 plan to help address the upstream factors impacting health disparities.
Futhermore, personalized medicine, the understanding that variables like genetics, environment, and lifestyle play a direct role in shaping an individual's response to identical treatment regimens or vaccines, is leading to an evolution in healthcare. Ultimately, each person's unique lived experience, impacted by environment, ethnicity, age, gender, and other societal factors becomes the foundation for their physical and mental well-being.
The Crucial Role of Diversity in Patient Recruitment for Clinical Research Studies
When applied to clinical research, the recognition of social determinants of health amplifies their impact on diverse lived experiences. The imperative arises for our society to ensure the effectiveness of new treatments across all population subgroups. However, recent data reveals a predominant participation of white individuals in clinical research endeavors.
References:
- US Food and Drug Administration 2020 drug trials snapshot. Summary report.
https://www.fda.gov/media/145718/download
- US Food and Drug Administration. Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
Advancements in healthcare underscore the variability in how individuals experience the same disease, with certain medications exhibiting distinct efficacy across diverse populations, ages, or genders. It is crucial that safety and efficacy data from clinical research encompass the experiences of all subgroups before treatments receive approval and enter the market. The dearth of diversity in clinical research poses the risk of rendering medications and treatments less effective for specific subgroups.
A notable illustration of this discrepancy is evident in the varying efficacy of beta blockers and ACE inhibitors between individuals of White European and Black African ancestry.
Reference:
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.107.704023?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
More recently, during the Covid-19 pandemic, preliminary findings from the trial of Moderna’s Covid-19 vaccine were based on a predominantly White participant population—not an adequately representative sample of the U.S. population.
Defining Diversity in Patient Recruitment for Clinical Trials: Profound Research's Perspective
Examining Profound Research's approach to defining diversity involves delving into the specific criteria and considerations we employ. Our definition encompasses factors such as age, gender, ethnicity, socioeconomic status, and other relevant parameters. We adhere to validated (?) guidance from esteemed sources like the NIH and the FDA, utilizing a comprehensive framework that goes beyond conventional criteria. This includes incorporating nuanced parameters that profoundly impact the lived experience of individuals. Our commitment extends further to considering typically underrepresented therapeutic areas or conditions and addressing data gaps across various subpopulations.
References:
https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html
https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity
Strategies Employed by Profound Research to Enhance Diversity in Patient Recruitment Across Demographic Groups
Profound Research is committed to revealing the proactive measures and approaches undertaken to actively recruit and engage diverse patient populations, with the ultimate goal of ensuring a representative sample in clinical studies.
Our approach is multifaceted, commencing with a focus on geography. We strategically establish partnerships with sites in urban and metro areas. Building upon this foundation, we delineate geographic regions, positioning our sites as central hubs. Recognizing that potential participants prefer local accessibility, we aim to minimize travel distances for involvement in clinical trials or physician visits. Additionally, we actively immerse ourselves in these communities, participating in health fairs and providing screenings and related services. Through the dissemination of information and resources, our objective is to empower local patients, fostering a basis of trust within these communities. We envision the cultivation of this trust as a standard practice, allowing us to recruit patients from diverse backgrounds effectively.
Significance of Geographic Diversity in Patient Recruitment
Centrally addressing the importance of geographic diversity, this discussion emphasizes its pivotal role in advancing the overarching diversity objectives within clinical research studies. The exploration extends to encompass regional health variations, cultural distinctions, and the profound impact of local demographics on the outcomes of the studies.
Furthermore, the positioning of research sites in diverse regional hubs such as San Diego, Los Angeles, and Detroit, paired with diversity of staffing directly contribute to enhancing trial diversity. Recent findings from a white paper by Tufts Center for the Study of Drug Development underscore a significant correlation between the diversity of research site staff and the diversity observed among patients involved in clinical trials.
References: https://medicine.tufts.edu/news-events/news/increase-diversity-clinical-trials-first-increase-staff-diversity
In light of this insight, Profound Research strategically chooses urban areas characterized by vibrant and diverse populations. By establishing partnerships with sites committed to effective practices for engaging and enrolling diverse patients—bolstered by robust infrastructure and streamlined processes—the company is actively contributing to the delivery of expanded treatment options to those who need them most.
Strategies in Overcoming Diversity Challenges for Credible and Relevant Study Findings
Overcoming the primary challenge of recruiting diverse patient populations, particularly centered around trust, is a focal point for Profound Research. Over the years, a pervasive lack of trust has been observed among minority patients within the healthcare system, with historical incidents such as the syphilis research conducted by the U.S. Public Health Service at the Tuskegee Institute of Alabama exemplifying this issue. Language poses a secondary barrier, underscoring the importance of effective communication tailored to patients' comprehension levels regarding potential treatment benefits, possible side effects, and the significance of adherence to treatment regimens. Additionally, logistical hurdles like transportation, employment commitments, and childcare responsibilities can hinder participation.
To address these challenges comprehensively, Profound Research offers external support mechanisms to its research sites, allowing them to concentrate on patient care. Community events held at centers, religious organizations, and farmers markets play a crucial role in building and fostering a relationship of trust with diverse populations. The organization's dedicated team of patient engagement specialists consistently provides education and information to local patient communities, addressing disparities arising from limited access to education. Moreover, Profound has developed concierge-style patient support services, aiding with transportation, childcare, and other potential impediments that might otherwise deter diverse populations from participating in clinical trials.
Conclusion
At its core, individual health is shaped by the intertwined dynamics of physical and mental well-being, profoundly influenced by the lived experience and social determinants of health. Profound Research, by prioritizing diversity and ensuring access to treatment options for all, and through strategic partnerships with like-minded practices, is actively transforming the landscape of clinical research. This commitment aligns with the understanding that addressing diversity challenges and fostering inclusivity not only enhances the credibility and relevance of study findings but also contributes to a more comprehensive and equitable healthcare future.
About the Author: Currently serving as the Senior Director of Patient Recruitment and Engagement for Profound Research, Erem Latif, MS, MBA, is an innovative healthcare leader with experience in leveraging operational excellence, client relationship management and strategic marketing and communications to elevate brand, drive patient engagement, and optimize clinical outcomes. Furthermore, Erem offers a deep understanding of complex industry and proven methodologies to improve results for providers, health systems, and payers.
